What is a clinical trial protocol?

Epidemiol Psichiatr Soc. 2010 Apr-Jun;19(2):116-7.


Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.

MeSH terms

  • Clinical Protocols*
  • Clinical Trials as Topic / standards*
  • Humans